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hydroxyethyl starch, hydroxyethyl starch combinations

As the list published 23 Sept 2026 has it, binding since 4 Sept 2026. Each entry binds six months after its own publication date (Article 107c(7) of Directive 2001/83/EC).

What the list says

EU reference date
Not stated
PSUR frequency
1 year
Data lock point
1 Mar 2026
Submission date
10 May 2026
Next data lock point
1 Mar 2027
Next submission date
10 May 2027
Products covered
Nationally authorised (NAP)

Are PSURs required for products referred to in Articles 10(1), 10a and 16a of Directive 2001/83/EC?

No — the list does not require PSURs for these products.

The list asks this as one question for Articles 10(1), 10a and 16a together, and does not answer it for Article 14 at all. A PSUR may in any case be required at the request of a competent authority or as a condition of the marketing authorisation.

Notes in the list

Active substance name was amended on 04/03/2026 DLP was amended on 22/10/2025

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The next three reports

  • Data lock point 1 Mar 2027Submission by 10 May 2027
  • Data lock point 1 Mar 2028Submission by 10 May 2028
  • Data lock point 1 Mar 2029Submission by 10 May 2029

Counted from the data lock point the list gives, on the cycle it states: the submission date is 70 days after the data lock point — 70 days for a cycle of twelve months or less, 90 days for a longer one, as GVP Module VII sets out.

In earlier versions of the list

  • EMA/630645/2012 Rev.164 · published 23 Sept 2026

    hydroxyethyl starch, hydroxyethyl starch combinations — every 1 year, data lock point 1 Mar 2027

  • EMA/630645/2012 Rev.156 · published 4 Feb 2026

    hydroxyethyl starch / sodium chloride — every 1 year, data lock point 1 Mar 2027

Source: European Medicines Agency, list of EU reference dates and frequency of submission of periodic safety update reports, EMA/630645/2012 Rev.164, published 23 Sept 2026. Open the published file

Kreastel is a planning and oversight aid for pharmacovigilance obligations. It tracks dates like these for a marketing authorisation holder's own products.

Report a discrepancy — if this page and the published file disagree, the file is right and we want to know.

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